- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01730261
Online Emotional Regulation Group Treatment
October 1, 2015 updated by: Icahn School of Medicine at Mount Sinai
Online Emotional Regulation Group Treatment for Individuals With Traumatic Brain Injury (TBI)
This study will examine the feasibility of online delivery of emotional regulation training to individuals with TBI with emotional dysregulation.
80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online in group modality.
Attendance and compliance will be tracked, and outcomes will be monitored using online data collection methods.
Treatment satisfaction and participant subjective experience will also be assessed.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This study will examine the feasibility of online delivery of emotional regulation training to individuals with Traumatic Brain Injury who also have emotional dysregulation.
80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online via a group meeting software.
Study participation will last 28 weeks: 4 weeks of baseline, 12 weeks of treatment (24 sessions) and 12 weeks of follow-up.
Assessments will be conducted at each of four timepoints: T1 (baseline), T2 (pre-treatment assessment), T3 (end-of-treatment assessment) and T4 (follow-up assessment).
In addition, a subset of the measures will be administered bi-weekly for the duration of the study.
Assessments will consist of a variety of measures designed to measure executive functioning, problem solving skills, and quality of life.
All assessments will be completed online, using a web-based data collection.
Attendance and treatment compliance will be tracked, and outcomes will be monitored using online data collection methods.
Treatment satisfaction and participant subjective experience (including technical difficulties that make access to web-delivered treatment impossible) will also be assessed.
Study Type
Interventional
Enrollment (Actual)
147
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10029
- The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Documented TBI of any severity and being at least 6 months post injury
- Presence of executive dysfunction, manifested as self-reported difficulties with emotional and behavioral self-regulation, operationalized as endorsement of 25% or more of the symptoms on the Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004).
- Currently aged 18 or older
- English speaking
- At least low average intellectual functioning, operationalized as a minimum Verbal IQ score of 80 on the Wechsler Abbreviated Scale of Intelligence
- Ownership of and relative facility with use of a computer, webcam, and microphone
- Access to a broadband internet connection at sufficiently high speed to allow videoconference
Exclusion Criteria:
- DSM-IV-TR diagnosis of alcohol or substance abuse within past 6 months
- DSM-IV-TR of psychosis within past 6 months
- High suicidality, operationalized as a score of 17 or higher on the Mini International Neuropsychiatric Interview (M.I.N.I., Sheehan et al., 2008)
Participation in this study will not preclude participation in other treatments.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Online Emotional Regulation Treatment
Participants will receive 24 treatment sessions, with baseline, post-treatment screening and follow-up screening, and bi-weekly assessments
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Emotional Regulation Training (EmReg) is a cognitive-behavioral approach which aims to increase awareness, and self-monitoring of affective states to improve self-regulation.
EmReg combines didactic and experiential training, and emphasizes skill acquisition and generalization through examination of incidents of emotional dysregulation in one's life and completion of homework assignments.
The treatment is divided into two phases: knowledge provision and practice facilitation.
During the knowledge provision phase participants are introduced to the objectives and the main concepts of the treatment, to increase their familiarity with the terminology, and to the emotional regulation skills they acquire during the practice facilitation phase.
During the practice facilitation phase participants receive training in emotional regulation skills, which they practice in-session with the guidance of the therapist and feedback from the group, as well as out-of-session as homework assignments.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difficulties in Emotion Regulation Scale(DERS)
Time Frame: up to 28 weeks
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36-item self-report questionnaire that focuses on emotional awareness, acceptance, ability to control impulsivity, and flexible use of strategies
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up to 28 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ)
Time Frame: up to 28 weeks
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32 item self-report questionnaire assessing deficits in emotion regulation, developed specifically to assess emotional dysregulation related to TBI
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up to 28 weeks
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Problem Solving Inventory
Time Frame: up to 28 weeks
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35-item self-report questionnaire assessing problem solving capability
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up to 28 weeks
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Social Problem Solving Inventory-Revised: Short Form
Time Frame: up to 28 weeks
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25-item self-report questionnaire assessing problem solving in everyday living
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up to 28 weeks
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Positive Affect Negative Affect Scale
Time Frame: up to 28 weeks
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20-item self-report measure of positive and negative affect within a specified time frame
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up to 28 weeks
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Satisfaction with Life Scale
Time Frame: T1 (baseline)
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5- item measure of global satisfaction with life
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T1 (baseline)
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Satisfaction with Life Scale
Time Frame: T2 (week 4)
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5- item measure of global satisfaction with life
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T2 (week 4)
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Satisfaction with Life Scale
Time Frame: T3 (week 16)
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5- item measure of global satisfaction with life
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T3 (week 16)
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Satisfaction with Life Scale
Time Frame: T4 (week 28)
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5- item measure of global satisfaction with life
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T4 (week 28)
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Satisfaction with Therapy and Therapist Scale
Time Frame: T3 (week 16)
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12-item scale that assesses satisfaction with treatment and therapist
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T3 (week 16)
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Satisfaction with Therapy and Therapist Scale
Time Frame: T4 (week 28)
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12-item scale that assesses satisfaction with treatment and therapist
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T4 (week 28)
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Treatment Compliance
Time Frame: up to 28 weeks
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therapist's ratings of participant on each of the following areas at each session: attendance, participation, homework completion, skill acquisition, skill generalization, ease of use of technology, and interpersonal behavior
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up to 28 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
November 15, 2012
First Submitted That Met QC Criteria
November 15, 2012
First Posted (Estimate)
November 21, 2012
Study Record Updates
Last Update Posted (Estimate)
October 2, 2015
Last Update Submitted That Met QC Criteria
October 1, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 12-1256-3
- HSM 12-00760
- IF1435434
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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